Is Voluma (By Juvederm) FDA Approved Yet? If Not, Why Not? What Could Be the Concerns?
Is Voluma Filler FDA Approved?
Doctor Answers 56
Yay, Voluma is FDA approved. So what?
It is now 15 years since I have discovered and integrated “cosmetic medicine” into my aesthetic and reconstructive practice. Cosmetic medicine is the developing branch of non to minimally invasive non-surgical options one uses to enhance their aging process. Whether it be peri-menopausal hot flashes or wrinkles, whatever your medical insurer does not pay for and is perceived by you and the medical industry as personal physical or physiologic enhancement is considered “self-pay” and expanding into the Cosmetic Medicine industry. If such enhancements may have a actual biologic change in your body, it must be FDA approved before it can be marketed in the USA. If it is considered inert and does not actively change or stimulate your tissues to change, it may be marketed OTC (over-the-counter).
Voluma, is a volumizing gel which follows a lengthening list of cosmetic medicine options. It falls in a class of “anti-aging” enhancements called Fillers. This particular one is made by Allergan; is FDA approved this month as a hyaluronic acid gel filler for injection deep into the cheek. It has been labeled for cosmetic use but the class of hyaluronic acid gels are used in different medical formulations (therefore paid by insurance) for lubricating the knee joint, refilling the eyeball and other uses.
Cosmetic and medical fillers are used to replace or add volume to tissues which have lost the 3 dimensional mass from aging or trauma. The best and easiest example to understand is a breast augmentation using a saline (salt water) or gel implant in a young small breasted female or woman following pregnancy for cosmetic reasons or a breast reconstruction implant following breast tissue loss for cancer or injury.
Injectible volumizers have been around for 15 or more years and used to build up soft tissue loss, particularly in the face. Since it is biologically active it also stimulates a body’s immune response to create firming and integration, a process you enjoy and therefore choose to purchase. This process is called scar, or collagen formation and induces phases of swelling, bruising and increased circulation to the area and has many typical side-effects associated with any other injury to your tissues including prolonged discomfort, bruising, swelling, lumpiness, deformity, spider-veins, etc which is part of the “package”. The terrific aspect of Voluma is that it is cross-linked (like having more rungs holding a ladder together) so it lasts longer; up to 2 years. Side-effects can therefore last longer too! Another great thing about Voluma is that it is similar to the same molecule made in the body so it degrades with an enzyme, hyaluronidase, if it is not quite right.
Voluma as with other "HA" filler results are immediate but take 2-3 weeks for most of the side-effects and softening to occur. Depending on your metabolism and the site it is injected it will last longer or shorter duration. Since Voluma is highly linked, it is firmer and requires a deeper injection so you will not notice the rounding, lumpiness or irregularities as much as thinner products such as Juvederm. Also misunderstood is that the body's soft tissues are not one large blob but are compartmentalized into smaller areas. This is where the art of injection come in as your physician injecter must understand the anatomy to place these fillers properly.
I hope this has been helpful for you. Since the art of anti-aging and cosmetic medicine is based on science and individualized for you, please be choosey in finding your best Cosmetic MD possible!
All the best,
Dean Kane, MD, FACS
Even though not FDA approved for anything other than cheek augmentation, many injectors have had great success in treating other areas of the face such as the Hollows of the temple and the chin.
Hope this helps
Voluma is FDA approved for mid-face correction
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I love the dramatic results that my patients achieve, however, they look natural and refreshed, not fake and puffy.
I actually have it in my own face (because I'm old! LOL) and like the results.